A Study of Bevacizumab (Avastin) in Women With HER2 Negative Metastatic Breast Cancer
NCT ID: NCT00333775
Last Updated: 2016-01-27
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
736 participants
INTERVENTIONAL
2006-03-31
2013-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Docetaxel 100 mg/m^2 plus placebo
Participants received docetaxel 100 mg/m\^2 intravenously on Day 1 of each 3 week cycle for a maximum of 27 weeks (9 cycles). In addition, participants received placebo to bevacizumab intravenously on Day 1 of each 3 week cycle until disease progression, unacceptable toxicity, or participant withdrawal.
Docetaxel
Docetaxel was supplied in 2 vials, 1 containing docetaxel and 1 containing a solvent, for intravenous infusion.
Placebo to bevacizumab
Placebo to bevacizumab was supplied as a sterile liquid for intravenous infusion in single-use vials.
Docetaxel 100 mg/m^2 plus bevacizumab 7.5 mg/kg
Participants received docetaxel 100 mg/m\^2 intravenously on Day 1 of each 3 week cycle for a maximum of 27 weeks (9 cycles). In addition, participants received bevacizumab 7.5 mg/kg intravenously on Day 1 of each 3 week cycle until disease progression, unacceptable toxicity, or participant withdrawal.
Docetaxel
Docetaxel was supplied in 2 vials, 1 containing docetaxel and 1 containing a solvent, for intravenous infusion.
Bevacizumab
Bevacizumab was supplied as a sterile liquid for intravenous infusion in single-use vials.
Docetaxel 100 mg/m^2 plus bevacizumab 15.0 mg/kg
Participants received docetaxel 100 mg/m\^2 intravenously on Day 1 of each 3 week cycle for a maximum of 27 weeks (9 cycles). In addition, participants received bevacizumab 15.0 mg/kg intravenously on Day 1 of each 3 week cycle until disease progression, unacceptable toxicity, or participant withdrawal.
Docetaxel
Docetaxel was supplied in 2 vials, 1 containing docetaxel and 1 containing a solvent, for intravenous infusion.
Bevacizumab
Bevacizumab was supplied as a sterile liquid for intravenous infusion in single-use vials.
Interventions
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Docetaxel
Docetaxel was supplied in 2 vials, 1 containing docetaxel and 1 containing a solvent, for intravenous infusion.
Placebo to bevacizumab
Placebo to bevacizumab was supplied as a sterile liquid for intravenous infusion in single-use vials.
Bevacizumab
Bevacizumab was supplied as a sterile liquid for intravenous infusion in single-use vials.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Human epidermal growth factor receptor 2 (HER2)-negative cancer of the breast with locally recurrent or metastatic disease, suitable for chemotherapy.
* No adjuvant chemotherapy within 6 months before randomization, and no taxane-based chemotherapy within 12 months before randomization.
* Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
Exclusion Criteria
* Radiotherapy for treatment of metastatic disease.
* Other primary tumors within last 5 years, except for controlled limited basal cell or squamous cancer of the skin, or cancer in situ of the cervix.
* Spinal cord compression or brain metastases.
* Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to randomization.
* Inadequate bone marrow, liver, or renal function.
* Uncontrolled hypertension.
18 Years
FEMALE
No
Sponsors
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Hoffmann-La Roche
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Trials
Role: STUDY_DIRECTOR
Hoffmann-La Roche
Locations
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Adelaide, New South Wales, Australia
Camperdown, New South Wales, Australia
Westmead, New South Wales, Australia
Auchenflower, Queensland, Australia
Box Hill, Victoria, Australia
Fitzroy, Victoria, Australia
Ringwood East, Victoria, Australia
Perth, Western Australia, Australia
Graz, , Austria
Salzburg, , Austria
Vienna, , Austria
Vöcklabruck, , Austria
Brussels, , Belgium
Wilrijk, , Belgium
Goiânia, Goiás, Brazil
Belo Horizonte, Minas Gerais, Brazil
Porto Alegre, Rio Grande do Sul, Brazil
Florianópolis, Santa Catarina, Brazil
Barretos, São Paulo, Brazil
São Paulo, São Paulo, Brazil
Calgary, Alberta, Canada
Edmonton, Alberta, Canada
Vancouver, British Columbia, Canada
Halifax, Nova Scotia, Canada
Greater Sudbury, Ontario, Canada
Ottawa, Ontario, Canada
Toronto, Ontario, Canada
Montreal, Quebec, Canada
Québec, Quebec, Canada
Beijing, , China
Besançon, , France
Bordeaux, , France
Caen, , France
Clermont-Ferrand, , France
Dijon, , France
Lille, , France
Montpellier, , France
Villejuif, , France
Ansbach, , Germany
Berlin, , Germany
Düsseldorf, , Germany
Erlangen, , Germany
Frankfurt, , Germany
Frankfurt am Main, , Germany
Halle, , Germany
Hamburg, , Germany
Heidelberg, , Germany
Jena, , Germany
Lemgo, , Germany
München, , Germany
Stuttgart, , Germany
Trier, , Germany
Tübingen, , Germany
Ulm, , Germany
Bologna, Emilia-Romagna, Italy
Modena, Emilia-Romagna, Italy
Parma, Emilia-Romagna, Italy
Trieste, Friuli Venezia Giulia, Italy
Udine, Friuli Venezia Giulia, Italy
Treviglio, Lombardy, Italy
Biella, Piedmont, Italy
Taormina, Sicily, Italy
Macerata, The Marches, Italy
Kaunas, , Lithuania
Vilnius, , Lithuania
Mexicali, , Mexico
Mexico City, , Mexico
Mérida, , Mexico
Monterrey, , Mexico
Obregón, , Mexico
Puebla City, , Mexico
Sittard, , Netherlands
Utrecht, , Netherlands
Panama City, , Panama
Krakow, , Poland
Olsztyn, , Poland
Poznan, , Poland
Warsaw, , Poland
Wroclaw, , Poland
Coimbra, , Portugal
Lisbon, , Portugal
Bucharest, , Romania
Pretoria, , South Africa
Sandton, , South Africa
Seoul, , South Korea
Seoul, , South Korea
Seoul, , South Korea
Barcelona, Barcelona, Spain
Barcelona, Barcelona, Spain
Barcelona, Barcelona, Spain
Barcelona, Barcelona, Spain
Jaén, Jaen, Spain
Madrid, Madrid, Spain
Málaga, Malaga, Spain
Linköping, , Sweden
Lund, , Sweden
Umeå, , Sweden
Chur, , Switzerland
Kaohsiung City, , Taiwan
Taipei, , Taiwan
Taipei, , Taiwan
Bangkok, , Thailand
Bangkok, , Thailand
Khon Kaen, , Thailand
Bournemouth, , United Kingdom
Cambridge, , United Kingdom
Edinburgh, , United Kingdom
Leeds, , United Kingdom
Leeds, , United Kingdom
London, , United Kingdom
Manchester, , United Kingdom
Middlesex, , United Kingdom
Newcastle upon Tyne, , United Kingdom
Truro, , United Kingdom
Countries
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References
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Wedam SB, Beaver JA, Amiri-Kordestani L, Bloomquist E, Tang S, Goldberg KB, Sridhara R, Ibrahim A, Kim G, Kluetz P, McKee A, Pazdur R. US Food and Drug Administration Pooled Analysis to Assess the Impact of Bone-Only Metastatic Breast Cancer on Clinical Trial Outcomes and Radiographic Assessments. J Clin Oncol. 2018 Apr 20;36(12):1225-1231. doi: 10.1200/JCO.2017.74.6917. Epub 2018 Mar 9.
Other Identifiers
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2005-003862-40
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
BO17708
Identifier Type: -
Identifier Source: org_study_id
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